The U.S. Food and Drug Administration’s (FDA) independent advisory council has recommended that Pfizer’s vaccine for newborns, which offers protection against the respiratory syncytial virus (RSV), be given full clearance. However, at the advisory committee meeting, security issues about a possible connection between the vaccine and preterm deliveries were brought up. Despite the committee’s unanimity that the vaccine’s effectiveness findings were satisfactory, four experts voiced concerns about its safety.
The medical director of Children’s Mercy Hospital in Kansas City, Dr. Jay Portnoy, expressed hope for the vaccine’s potential to improve newborn health. However, Dr. Paul Offit of the Children’s Hospital of Philadelphia raised doubt over the safety information that was already available and emphasized possible dangers related to preterm deliveries.
Adam Berger, head of clinical and healthcare research policy at the National Institutes of Health, supported the vaccine’s effectiveness and safety but underlined the need for Pfizer to do post-marketing studies that particularly address the risk of preterm delivery.
The FDA is scheduled to make its final decision over the licensure of the vaccine in August, just before the start of the RSV season in the autumn, even though it generally takes into account the recommendations of its advisory committees.
Researchers have been working on developing a vaccine to protect children against RSV for decades, and if Pfizer’s application is approved, it will be the first one ever made. GlaxoSmithKline’s RSV vaccine was given FDA approval earlier this month for use in individuals 60 and older. In the next weeks, a decision on Pfizer’s RSV vaccine for the same age range is anticipated.
RSV is a common respiratory illness that may have serious side effects, especially in elderly people and small infants. RSV causes thousands of fatalities each year among elderly and hundreds among infants under five. One percent of infants under six months old who acquire RSV need hospitalization.
In order to convey protective antibodies to the baby, pregnant moms get Pfizer’s infant vaccination in the latter stages of pregnancy. RSV protection is provided by the single-dose vaccination from birth during the first six months of the infant’s life.
The safety information from a phase three study was the main source of worry for the advisory group. The experiment found that moms who got the vaccination had slightly more preterm deliveries than mothers who received a placebo. The observed difference, according to Pfizer and the FDA, was not statistically significant, however. Near the due dates, after 34 weeks of pregnancy, the majority of preterm deliveries occurred.
While the issue was being discussed, Dr. Hana El Sahly, the head of the FDA advisory group, voiced concern about the possible effects of late preterm births on newborns. Notably, preterm deliveries have been an issue in earlier RSV vaccination studies, including one carried out by GlaxoSmithKline, a rival of Pfizer.
Participants at the advisory conference, including respiratory diseases expert and consultant Dr. Daniel Feikin, raised concerns about the presence of a clear causal link between the vaccine and preterm births.
In response to the safety worries, Pfizer reps emphasized that the vaccine’s advantages surpass any potential hazards. No conclusive data, according to Dr. William Gruber, senior vice president of clinical research and development for vaccines at Pfizer, revealed a risk of preterm.
Some trial participants’ offspring had low birth weights and developmental impairments during the experiment. According to the FDA staff evaluation, the majority of women who got the immunization